美国参议员Thom Tillis提出新修法提案《2022专利适格性恢复法》（Patent Eligibility Restoration Act of 2022），编号S.4734[1]，准备修改35 U.S.C. 100(b)、新增35 U.S.C. 100(k)、重写35 U.S.C. 101，究竟美国专利法的适格性要件应该怎么个修法？新一轮政策拔河正式展开。
美国最高法院拒绝藉American Axle案[2]重新检视专利适格性判断标准，许多美国知识产权专家认为，这可视为是美国最高法院的表态：专利适格性问题宜由美国国会修法解决。为此，美国参议院司法委员会知识产权次级委员会副主席Thom Tillis 2022年8月2日提出新修法提案《2022专利适格性恢复法》（Patent Eligibility Restoration Act of 2022），编号S.4734[3]，究竟美国专利法的适格性要件应该怎么个修法？新一轮政策拔河正式展开。
S.4734修法重点大概可分为三项：修订35 U.S.C. 100(b)、新增35 U.S.C. 100(k)及重写35 U.S.C. 101。三大不可授予专利的司法例外（即自然现象、物理法则、抽象概念），依现行实务编入法典，但推翻美国最高法院Myriad、Mayo既有判例部分教示，对生技制业产业相对友善，同时明确定义适格性判准与35 U.S.C. 102、103、112无关。不过进一步检视这项提案的修法文字，何谓非技术性（non-technological）、制法步骤的储存及执行（storing and executing），诸如此类的用语，显然还有争执讨论空间。
修订35 U.S.C. 100(b)
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英文原文 |
中文说明 |
现行版本 |
The term "process" means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material. |
「制法」该词系指制程、技艺或方法，且包括一习知制法、机器、制品、物之组合或原料的新使用。 |
提案版本 |
The term "process" means process, art, or method, and includes a use, application, or method of manufacture of a known or naturally-occurring process, machine, manufacture, composition of matter, or material. |
「制法」该词系指制程、技艺或方法，且包括一习知或自然发生制法、机器、制品、物之组合或原料的使用、应用或制造方法。 |
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新增35 U.S.C. 100(k)
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英文原文 |
中文说明 |
提案版本 |
The term ‘useful’ means, with respect to an invention or discovery, that the invention or discovery has a specific and practical utility from the perspective of a person of ordinary skill in the art to which the invention or discovery pertains.”; and |
「实用的」该词系指，关于一发明或发现，对该发明或发现相关技艺的通常技术者而言，该发明或发现有一特定且实际用途；且 |
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重写35 U.S.C. 101
首先，现行版本第101条的标题是可予专利发明（Inventions patentable），且只有一段文字；提案版本标题改为专利适格性（Patent eligibility），把原该段文字标为(a)项、删除「新颖的」（new）文字，以与新颖性要件清楚区分，同时新增35 U.S.C. 101(b)、35 U.S.C. 101(c)条文。
依其提案，新版35 U.S.C. 101(a)法条文字如下：
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英文原文 |
中文说明 |
现行版本 |
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. |
发明或发现任何新颖而实用的制法、机器、制品或物之组合，或前述各项任何新颖而实用的改良者，如符合本法规范及要件，可获其专利。 |
提案版本 |
(a) In General.—Whoever invents or discovers any useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent therefor, subject only to the exclusions in subsection (b) and to the further conditions and requirements of this title. |
(a) 总说 ─ 发明或发现任何实用的制法、机器、制品或物之组合，或前述各项任何实用的改良者，如进而符合本法规范及要件，除非为(b)项所列例外，可获其专利。 |
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35 U.S.C. 101(b)新增法条文字如下所列：
英文原文 |
中文说明 |
Eligibility Exclusions.— |
适格性排除 ─ |
(1) IN GENERAL.—Subject to paragraph (2), a person may not obtain a patent for any of the following, if claimed as such: |
(1) 总说 ─ 除非符合本项(2)规范，一人所请发明若仅如以下所列，不得获其专利： |
(A) A mathematical formula, apart from a useful invention or discovery. |
(A) 一数学程序，不含一实用的发明或发现。 |
(B) A process that— |
(B) 一制法 ─ |
(i) is a non-technological economic, financial, business, social, cultural, or artistic process; |
(i) 系非技术性的经济、金融、商业、社会、文化或艺术面加工； |
(ii) is a mental process performed solely in the human mind; or |
(ii) 系一纯于人类内心实施的心智历程；或 |
(iii) occurs in nature wholly independent of, and prior to, any human activity. |
(iii) 完全独立于且先于人类活动，自然产生。 |
(C) An unmodified human gene, as that gene exists in the human body. |
(C) 一未经改造的人类基因，同于人体内所存基因。 |
(D) An unmodified natural material, as that material exists in nature. |
(D) 一未经改造的天然原料，同于自然界所存原料。 |
(2) CONDITIONS.— |
(2) 规范 ─ |
(A) CERTAIN PROCESSES.—Notwithstanding paragraph (1)(B)(i), a person may obtain a patent for a claimed invention that is a process described in such provision if that process is embodied in a machine or manufacture, unless that machine or manufacture is recited in a patent claim without integrating, beyond merely storing and executing, the steps of the process that the machine or manufacture perform. |
(A) 部分制法 ─ 纵使落入本项(1)(B)(i)，即一人所请发明系如其描述的制法，只要该制法体现于机器或制品内，仍可获其专利，除非申请专利范围虽写入该机器或制品，但于储存及执行之外，未捆绑该机器或制品实施的[其他]制法步骤。 |
(B) HUMAN GENES AND NATURAL MATERIALS.—For the purposes of subparagraphs (C) and (D) of paragraph (1), a human gene or natural material that is isolated, purified, enriched, or otherwise altered by human activity, or that is otherwise employed in a useful invention or discovery, shall not be considered to be unmodified. |
(B) 人类基因及天然原料 ─ 按本项(1)(C)及(D)，一人类基因或天原料经分离、纯化、浓缩或经其他人类活动变更，或在一实用的发明或发现作其他使用，不应视为未经改造。 |
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35 U.S.C. 101(c)新增法条文字如下：
英文原文 |
中文说明 |
Eligibility.— |
适格性 ─ |
(1) IN GENERAL.—In determining whether, under this section, a claimed invention is eligible for a patent, eligibility shall be determined— |
(1) 总说 ─ 判断一所请发明依本条是否为专利适格客体时，适格性判断应 ─ |
(A) by considering the claimed invention as a whole and without discounting or disregarding any claim element; and |
(A) 考虑该所请发明整体，勿忽视或无视任何申请专利范围组件；且 |
(B) without regard to— |
(B) 不考虑 ─ |
(i) the manner in which the claimed invention was made; |
(i) 该所请发明产生方式； |
(ii) whether a claim element is known, conventional, routine, or naturally occurring; |
(ii) 一申请专利范围组件是否习知、传统、例行，或自然发生； |
(iii) the state of the applicable art, as of the date on which the claimed invention is invented; or |
(iii) 截至该所请发明的发明日，相关技术先前技术；或 |
(iv) any other consideration in section 102, 103, or 112. |
(iv) 载于102、103，或112条的其他考虑。 |
(2) INFRINGEMENT ACTION.— |
(2) 侵权之诉 ─ |
(A) IN GENERAL.—In an action brought for infringement under this title, the court, at any time, may determine whether an invention or discovery that is a subject of the action is eligible for a patent under this section, including on motion of a party when there are no genuine issues of material fact. |
(A) 总说 ─ 依本法所提侵权之诉，法院随时可确认系争发明或发现依本条是否为专利适格客体，包括重大事实无实质争点时有当事人提出动议。 |
(B) LIMITED DISCOVERY.—With respect to a determination described in subparagraph (A), the court may consider limited discovery relevant only to the eligibility described in that subparagraph before ruling on a motion described in that subparagraph. |
(B) 有限证据开示 ─ 本款(A)所述确认，法院就是类动议作成裁决前，可考虑仅与其适格性相关的有限证据开示事证。 |
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